Reporting completeness of nutrition and diet-related randomised controlled trials protocols.

Gilberto Kac, Michael Schlussel, Celeste Naude, Dongquan Bi, Taciana Maia de Sousa, Marina Tavares, Amanda C Cunha Figueiredo, Shaima Saleh, Flávia Moraes Silva, Leila Cheikh Ismail, Colby J Vorland, Neha Khandpur, Gary S Collins, Mae Chester-Jones, Solange Durão, Simone Bernardes, Júlia Lima, Shona Kirtley, Jenneffer Rayane Braga Tibaes, Fabio Gomes, Sally Hopewell, Sarah Lamb, Matthew J Page, Cintia Curioni, Fernanda Rebelo, Jaqueline da Silva Fink, Jonathan Cook, Amanda Rodrigues Amorim Adegboye

Journal: Clinical nutrition (Edinburgh, Scotland) 2024;43(7):1626-1635

PMID: 38795681

Full Text on Elsevier Science View on PubMed

Abstract

BACKGROUND AND AIMS

There is a need to consolidate reporting guidance for nutrition randomised controlled trial (RCT) protocols. The reporting completeness in nutrition RCT protocols and study characteristics associated with adherence to SPIRIT and TIDieR reporting guidelines are unknown. We, therefore, assessed reporting completeness and its potential predictors in a random sample of published nutrition and diet-related RCT protocols.

METHODS

We conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis.

RESULTS

The majority of protocols included adults and elderly as their study population (n = 73; 36.5%), supplementation as intervention (n = 96; 48.0%), placebo as comparator (n = 89; 44.5%), and evaluated clinical status as the outcome (n = 80; 40.0%). Most protocols described a parallel RCT (n = 188; 94.0%) with a superiority framework (n = 141; 70.5%). Overall reporting completeness was 52.0% (SD = 10.8%). Adherence to SPIRIT items ranged from 0% (n = 0) (data collection methods) to 98.5% (n = 197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n = 11) (materials used in the intervention) to 98.5% (n = 197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [β = 0.53 (95%CI: 0.28-0.78)], most recent published protocols [β = 3.19 (95%CI: 0.24-6.14)], request of reporting guideline checklist during the submission process by the journal [β = 6.50 (95%CI: 2.56-10.43)] and mention of SPIRIT by the authors [β = 5.15 (95%CI: 2.44-7.86)] are related to higher reporting completeness scores.

CONCLUSIONS

Reporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals' endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols.

Address: Nutrition Department and Graduate Program of Nutrition Science, Federal University of Health Science of Porto Alegre, Brazil.; Research Centre for Healthcare & Communities, Coventry University, Coventry, UK; Centre for Agroecology, Water and Resilience (CAWR), Coventry University, UK.; Department of Nutrition in Public Health, State University of Rio de Janeiro, Brazil.; Pan-American Health Organisation, World Health Organisation, Washington DC, USA.; UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK.; Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Brazil.; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.; Department of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, P. O. Box 27272 Sharjah, United Arab Emirates; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK.; Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.; Division of Human Nutrition and Health, Washington University, Department of Nutrition, University of São Paulo, Brazil; Department of Nutrition, Harvard T.H. Chan School of Public Health, USA.; College of Medicine and Health, University of Exeter, Exeter, UK.; Department of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, P. O. Box 27272 Sharjah, United Arab Emirates.; Health Systems Research Unit, South African Medical Research Council, South Africa.; Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, USA.; Oracle Life Sciences, São Paulo, Brazil.; Clinical Research Unit, National Institute of Women, Children and Adolescents Health Fernandes Figueira (IFF), Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.; Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Brazil; Health Science Center, Serra dos Órgãos University Center, Rio de Janeiro, Brazil.; Department of Agricultural, Food and Nutritional Science, University of Alberta, Canada.; Independent Researcher, Brazil.; Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health. Faculty of Medicine and Health Sciences. Stellenbosch University, Cape Town, South Africa.; UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK. Electronic address: [email protected].

DOI: 10.1016/j.clnu.2024.04.038

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MeSH Terms: Humans, Checklist, Diet, Randomized Controlled Trials as Topic, Research Design, SARS-CoV-2, Clinical Trial Protocols as Topic, Editorial Policies, Periodicals as Topic, Guidelines as Topic